FDA 510(k)

CrossWise RF 腦室進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C）；CrossWise RF 适配器電纜（型號 CW-1002）

K 號：K241414 · 2024-09-26

決定日期2024-09-26

產品代碼DXF

諮詢委員會履歷

決定相當於

器材摘要

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241414. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K241414.

When did CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) receive FDA 510(k) clearance?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241414.

Who is the listed applicant for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

The FDA 510(k) record lists Circa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

The FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is DXF.

其他以 Circa Scientific, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251007CrossWise RF 腺中隔進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C、CW-1085C、CW-1085V、CW-1013F）K243954PeriCross™ 心外膜進入套件 K243193Cross Wise™ 多功能RF轉接線 K240004CardioCurve 可導導管小彎曲，40cm (CC-1040S)；CardioCurve 可導導管中彎曲，40cm (CC-1040M)；CardioCurve 可導導管大彎曲，40cm (CC-1040L)；CardioCurve 可導導管小彎曲，61cm (CC-1061S)；CardioCurve 可導導管中彎曲，61cm (CC-1061M)；CardioCurve 可導導管大彎曲，61cm (CC-1061L)；CardioCurve 可導導管小彎曲，71cm (CC-1071S)；CardioCurve 可導導管中彎曲，71cm (CC-1071M)；CardioCurve Steer K222311CIRCA MATRIX12 M 食管溫度探針及溫度監測系統

相關器械（代碼：DXF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261745雷電導管穿隔穿刺系統 (TPS)ElectroWire Medical K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLC K260292HOTWIRE RF 線導管（901XXX）；HOTWIRE RF 線導管（902XXX）Atraverse Medical K252419HOTWIRE RF 線導管（901XXX）；HOTWIRE RF 線導管（902XXX）Atraverse Medical, Inc.K251007CrossWise RF 腺中隔進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C、CW-1085C、CW-1085V、CW-1013F）Circa Scientific, Inc.K243193Cross Wise™ 多功能RF轉接線Circa Scientific, Inc.

官方來源

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